EP1374788B1 - Système d'électrochirurgie - Google Patents

Système d'électrochirurgie Download PDF

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Publication number
EP1374788B1
EP1374788B1 EP03253587A EP03253587A EP1374788B1 EP 1374788 B1 EP1374788 B1 EP 1374788B1 EP 03253587 A EP03253587 A EP 03253587A EP 03253587 A EP03253587 A EP 03253587A EP 1374788 B1 EP1374788 B1 EP 1374788B1
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EP
European Patent Office
Prior art keywords
electrodes
radio frequency
electrosurgical system
controller
characteristic
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
Application number
EP03253587A
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German (de)
English (en)
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EP1374788A1 (fr
Inventor
Alistair Ian Fleming
Huw Leonard Jones
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Gyrus Medical Ltd
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Gyrus Medical Ltd
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/1206—Generators therefor
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00642—Sensing and controlling the application of energy with feedback, i.e. closed loop control
    • A61B2018/00648—Sensing and controlling the application of energy with feedback, i.e. closed loop control using more than one sensed parameter
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00696—Controlled or regulated parameters
    • A61B2018/00702—Power or energy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00773—Sensed parameters
    • A61B2018/00827—Current
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00773—Sensed parameters
    • A61B2018/00875—Resistance or impedance
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00636—Sensing and controlling the application of energy
    • A61B2018/00773—Sensed parameters
    • A61B2018/00892—Voltage
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
    • A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
    • A61B18/14—Probes or electrodes therefor
    • A61B2018/1472—Probes or electrodes therefor for use with liquid electrolyte, e.g. virtual electrodes

Definitions

  • This invention as set out in the appended claims relates to an electrosurgical system, and in particular to one in which an electrosurgical generator provides a radio frequency (RF) cutting signal to a bipolar surgical instrument.
  • RF radio frequency
  • a typical bipolar cutting instrument which may also be capable of tissue coagulation, comprises first and second electrodes separated by an insulating spacer.
  • An early example of a bipolar RF cutting device is US 4,706,667 issued to Roos, in which the return or "neutral" electrode is set back from the active electrode.
  • Stasz proposed a variety of cutting blade designs. These were designed with relatively small gaps between two electrodes such that arcing would occur therebetween when an RF signal was applied to the blade, the arcing causing the cutting of the tissue.
  • a device in which the spacing of the electrodes is designed such that direct arcing between the electrodes does not occur, but arcing does occur between one of the electrodes and the tissue at the target site.
  • This may be by way of a failure of the insulating material forming the spacer, either by the insulating material experiencing such high temperatures that it becomes conductive, or by the temperature differentials throughout the insulator causing a physical cracking of the material. Alternatively, the extreme temperatures caused by the current flow may produce a physical melting of the electrode material itself.
  • an electrosurgical system including an RF generator; an electrosurgical instrument comprising at least first and second electrodes and an insulating spacer separating the first and second electrodes, the RF generator being adapted to supply a RF signal between the first and second electrodes, the signal being capable of causing tissue vaporisation means for measuring a characteristic of the output of the RF generator; and a controller adapted to analyse the measured characteristic and change the RF signal supplied between the first and second electrodes when an aspect of the characteristic exhibits rapid changes indicating the onset of a "flare-out" caused by debris forming a conductive track between the electrodes, allowing current to flow directly therebetween.
  • the characteristic of the output of the RF generator which is measured is the voltage across the first and second electrodes, or alternatively the current flowing therebetween. It has been discovered that there are a number of criteria which may indicate the onset of a flare-out. These include rapid changes in the impedance experienced between the electrodes, leading to large and sudden changes in the voltage between the electrodes or the current flowing therebetween. There may be an increase in the number or amplitude of high frequency components of the current or voltage signal, or an increase in the D.C. thermionic current sensed between the electrodes.
  • the controller is responsive to the changeability of the measured characteristic as indicative of the onset of flare-out, typically the rate of change of the impedance between the electrodes, or the changeability as represented by the sum of the differences between successive impedance measurements.
  • the controller is adapted to change the RF signal by reducing the power thereof when the aspect of the measured characteristic exhibits rapid changes.
  • the controller may reduce the voltage of the radio frequency signal, or even the frequency thereof.
  • the controller may change the signal by adjusting the relative proportions of the first and second frequency components.
  • the controller is adapted to reduce the power of the RF signal, and may reduce it substantially to zero in response to rapid changes of the measured characteristic.
  • the power is reduced substantially to zero for a period of at least 5 seconds, allowing time for the instrument to be withdrawn from the surgical site and the electrodes to be cleaned if necessary. Alternatively the power is reduced to zero until the operator of the instrument manually resets the instrument.
  • the controller is adapted to reduce the power of the RF signal supplied between the first and second electrodes only when the aspect of the characteristic exhibits rapid changes for a predetermined period of time. This serves to ensure that false detection of a flare-out is not triggered by a transient change in the measured characteristic.
  • the system may require a series of repeated measurements of the characteristic to all fit a predetermined criterion before action is taken.
  • the present invention is primarily designed to be employed with instruments in which the first and second electrodes and the insulating spacer are such that the spacing between the electrodes is between 0.25 mm and 3.0 mm.
  • an electrosurgical system includes an RF generator, an electrosurgical instrument comprising at least first and second electrodes and an insulating spacer separating the first and second electrodes, the RF generator being adapted to supply a RF signal between the first and second electrodes, means for measuring the impedance between the first and second electrodes, and a controller adapted to analyse the impedance measurements and interrupt the radio frequency signal supplied between the first and second electrodes when the changeability of the impedance exceeds a predetermined threshold value.
  • an electrosurgical system which does not form part of the invention and which comprises an RF generator having a pair of output terminals, and an electrosurgical instrument having a bipolar electrode assembly in the form of first and second electrodes adjacent each other and insulated from each other by a spacer, the electrodes being connectible to the output terminals, wherein the generator includes means for generating a monitoring signal representative of an electrical parameter associated with signals developed across the electrodes, and a controller responsive to the monitoring means to change the RF signal supplied by the generator to the instrument when the monitoring signal meets a predetermined criterion indicative of the onset of flare-out.
  • the predetermined criterion is the variability of the electrical parameter or the monitoring signal reaching or exceeding a predetermined level.
  • the electrical parameter is the load impedance across the generator output terminals and the controller is arranged to generate the sum of the differences between successive samples of the monitoring signal taken over a predetermined measurement period as a representation of the variability of the parameter.
  • a generator 10 has an output socket 10S providing an RF output for an instrument 12 via a connection cord 14. Activation of the generator may be performed from the instrument 12 via a connection in cord 14 or by means of a footswitch unit 16, as shown, connected to the rear of the generator by a footswitch connection cord 18.
  • Footswitch unit 16 has two footswitches 16A and 16B for selecting a coagulation mode and a cutting mode of the generator respectively.
  • the generator front panel has push buttons 20 and 22 for respectively setting coagulation and cutting power levels, which are indicated in a display 24. Push buttons 26 are provided as an alternative means for selection between coagulation and cutting modes.
  • the instrument 12 comprises a blade shown generally at 1 and including a generally flat first electrode 2, a larger second electrode 3 and an electrical insulator 4 separating the first and second electrodes.
  • the first electrode 2 is formed of stainless steel while the second electrode 3 is formed from copper integrally with a body portion 9.
  • the surface of the second electrode is plated with a biocompatible material such as stainless steel, or alternatively with a non-oxidising material such as gold, platinum or palladium.
  • the electrical insulator 4 is formed from a ceramic material such as Al 2 O 3 .
  • a conductive lead 5 is connected to the first electrode 2, while another conductive lead 6 is connected to the second electrode 3.
  • the RF output from the generator 10 is connected to the blade 1 via the leads 5 and 6 so that a radio frequency signal having a substantially constant peak voltage (typically around 400V) appears between the first and second electrodes.
  • a radio frequency signal having a substantially constant peak voltage typically around 400V
  • the RF voltage causes arcing between one of the electrodes and the tissue surface.
  • the first electrode 2 is smaller in cross-sectional area, and has a lower thermal capacity and conductivity than that of the second electrode 3, the first electrode assumes the role of the active electrode and arcing occurs from this electrode to the tissue.
  • Electrical current flows through the tissue to the second electrode 3, which assumes the role of the return electrode. Cutting of the tissue occurs at the active electrode, and the blade may be moved through the tissue.
  • the generator comprises an RF power oscillator 60 having a pair of output lines 60C for coupling via output terminals 62 to the load impedance 64 represented by the instrument 12 when in use. Power is supplied to the oscillator 60 by a switched mode power supply 66.
  • the RF oscillator 60 operates at about 400kHz, with any frequency from 300kHz upwards into the HF range being feasible.
  • the switched mode power supply typically operates at a frequency in the range of from 25 to 50kHz.
  • a microprocessor controller 72 coupled to the operator controls and display (shown in Figure 1 ) is connected to a control input 66A of the power supply 66 for adjusting the generator output power by supply voltage variation and to a threshold-set input 68C of the voltage threshold detector 68 for setting peak RF output voltage limits.
  • Also coupled across the output lines 60C is a current detection circuit 80 which feeds signals to the controller 72 via line 81.
  • the microprocessor controller 72 causes power to be applied to the switched mode power supply 66 when electrosurgical power is demanded by the surgeon operating an activation switch arrangement which may be provided on a handpiece or footswitch (see Figure 1 ).
  • a constant output voltage threshold is set independently on the supply voltage via input 68C according to control settings on the front panel of the generator (see Figure 1 ).
  • the threshold is set at a desiccation threshold value between 150 volts and 200 volts.
  • the threshold is set to a value in the range of from 250 or 300 volts to 600 volts.
  • These voltage values are peak values. Their being peak values means that for desiccation at least it is preferable to have an output RF waveform of low crest factor to give maximum power before the voltage is clamped at the values given. Typically a crest factor of 1.5 or less is achieved.
  • the status of the control input 60I of the RF oscillator 60 (which is connected to the "on" time control circuit 70) is "on", such that the power switching device which forms the oscillating element of the oscillator 60 is switched on for a maximum conduction period during each oscillation cycle.
  • the power delivered to the load 64 depends partly on the supply voltage applied to the RF oscillator 60 from the switched mode power supply 66 and partly on the load impedance 64.
  • the voltage threshold for a desiccation output is set to cause trigger signals to be sent to the "on" time control circuit 70 and to the switched mode power supply 66 when the voltage threshold is reached.
  • the "on" time control circuit 70 has the effect of virtually instantaneously reducing the "on” time of the RF oscillator-switching device. Simultaneously, the switched mode power supply is disabled so that the voltage supplied to oscillator 60 begins to fall.
  • the operation of the generator in this way is described in detail in our European Patent Application No. 0754437 .
  • the current is measured across the load 64 by the current detector 80 and the current value is sent to the controller 72.
  • the controller uses the current value to determine repeatedly the impedance across the load 64. The difference between successive impedance values is calculated, and summed for 16 consecutive readings to give a first total Z 1
  • the current measurements continue every 10ms until a further 16 consecutive impedance calculations have been made, which calculations are again summed to give a second total Z 2 . If Z 1 and Z 2 are both less than the threshold criteria for the sum Q of the impedance changes, then the generator continues to supply RF signals to the instrument 12. The process is continued with further current measurements being sent to the controller 72 every 10ms. This normal operation is shown in Figure 4 , in which the voltage across the electrodes 2, 3 is shown by trace 31, the current flowing by trace 32 and the impedance measured by the generator by trace 33.
  • the controller may cause a message (such as "Clean Tip") to be displayed by the display 24.
  • a message such as "Clean Tip"
  • the controller does not allow power to be restored to the output of the generator until the surgeon has pressed a reset button to indicate that the tip has been cleaned, and will repeat the interruption process if the impedance measurements show that the flare-out conditions are still in existence when the power is recommenced.
  • Some aspects of the present description could also be used to prevent overheating of electrodes without the actual existence of a flare-out.
  • the generator detecting that a criterion indicating the start of a potential overheating situation has been met, could reduce the power or alter the radio frequency signal in other ways so as to maintain operation of the electrosurgical system within proper parameters.
  • Those skilled in the art of electrosurgical generators wil readily be able to establish suitable detection criteria to keep the generator operating within safe and effective limits.
  • the present invention is set out in the appended claims.

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Molecular Biology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Plasma & Fusion (AREA)
  • Physics & Mathematics (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Otolaryngology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)
  • External Artificial Organs (AREA)

Claims (11)

  1. Système d'électrochirurgie comprenant :
    un générateur à haute fréquence (10) ;
    un instrument électrochirurgical (12) comprenant au moins des première et deuxième électrodes (2, 3) et un dispositif d'espacement isolant (4) séparant les première et deuxième électrodes, le générateur à haute fréquence étant adapté pour fournir un signal de haute fréquence entre les première et deuxième électrodes, le signal pouvant provoquer une vaporisation du tissu ;
    des moyens pour mesurer une caractéristique de la sortie du générateur à haute fréquence ;
    un contrôleur (72) adapté pour analyser la caractéristique mesurée et changer le signal de haute fréquence fourni entre les première et deuxième électrodes, caractérisé en ce que le contrôleur change ledit signal de haute fréquence, lorsqu'un aspect de la caractéristique laisse apparaître des changements rapides indiquant le début d'un « arrondi » provoqué par les débris formant une voie conductrice entre les électrodes (2, 3), permettant au courant de s'écouler directement entre elles.
  2. Système d'électrochirurgie selon la revendication 1, dans lequel la caractéristique de la sortie du générateur à haute fréquence (10) est la tension sur les première et deuxième électrodes.
  3. Système d'électrochirurgie selon la revendication 1, dans lequel la caractéristique de la sortie du générateur à haute fréquence (10) est le courant s'écoulant entre les première et deuxième électrodes.
  4. Système d'électrochirurgie selon l'une quelconque des revendications précédentes, dans lequel le contrôleur (72) est sensible au changement de la caractéristique mesurée pour changer ledit signal de haute fréquence.
  5. Système d'électrochirurgie selon la revendication 4, dans lequel le changement de la caractéristique mesurée est répété par la somme de différences entre les mesures successives de la caractéristique.
  6. Système d'électrochirurgie selon l'une quelconque des revendications précédentes, dans lequel le contrôleur (72) est adapté pour changer le signal de haute fréquence en réduisant la puissance du signal de haute fréquence lorsque l'aspect de la caractéristique laisse apparaître des changements rapides.
  7. Système d'électrochirurgie selon l'une quelconque des revendications précédentes, dans lequel le contrôleur (72) est adapté pour réduire la puissance du signal de haute fréquence sensiblement à zéro lorsque l'aspect de la caractéristique laisse apparaître des changements rapides.
  8. Système d'électrochirurgie selon la revendication 7, dans lequel le contrôleur (72) est adapté pour réduire la puissance du signal de haute fréquence sensiblement à zéro pendant une période minimum de 5 secondes.
  9. Système d'électrochirurgie selon la revendication 7, dans lequel le contrôleur (72) est adapté pour réduire la puissance du signal de haute fréquence sensiblement à zéro jusqu'à ce qu'un utilisateur du système se charge d'une opération de réinitialisation manuelle.
  10. Système d'électrochirurgie selon l'une quelconque des revendications précédentes, dans lequel le contrôleur (72) est adapté pour réduire la puissance du signal de haute fréquence fourni entre les première et deuxième électrodes, uniquement lorsque l'aspect de la caractéristique laisse apparaître des changements rapides pendant une période de temps prédéterminée.
  11. Système d'électrochirurgie selon l'une quelconque des revendications précédentes, lorsque les première et deuxième électrodes (2, 3) et le dispositif d'espacement isolant (4) sont tels que l'espacement entre les première et deuxième électrodes est compris entre 0,25 mm et 3,0 mm.
EP03253587A 2002-06-27 2003-06-06 Système d'électrochirurgie Expired - Lifetime EP1374788B1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB0214907A GB2390024B (en) 2002-06-27 2002-06-27 Electrosurgical system
GB0214907 2002-06-27

Publications (2)

Publication Number Publication Date
EP1374788A1 EP1374788A1 (fr) 2004-01-02
EP1374788B1 true EP1374788B1 (fr) 2011-10-12

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EP (1) EP1374788B1 (fr)
AT (1) ATE527953T1 (fr)
GB (1) GB2390024B (fr)

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US8499993B2 (en) 2006-09-29 2013-08-06 Ethicon Endo-Surgery, Inc. Surgical staple cartridge
US8534528B2 (en) 2007-06-04 2013-09-17 Ethicon Endo-Surgery, Inc. Surgical instrument having a multiple rate directional switching mechanism
US8905977B2 (en) 2004-07-28 2014-12-09 Ethicon Endo-Surgery, Inc. Surgical stapling instrument having an electroactive polymer actuated medical substance dispenser
US11304702B2 (en) 2013-09-13 2022-04-19 Cilag Gmbh International Surgical clip having compliant portion

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US8992422B2 (en) 2006-03-23 2015-03-31 Ethicon Endo-Surgery, Inc. Robotically-controlled endoscopic accessory channel
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US10568652B2 (en) 2006-09-29 2020-02-25 Ethicon Llc Surgical staples having attached drivers of different heights and stapling instruments for deploying the same
US10130359B2 (en) 2006-09-29 2018-11-20 Ethicon Llc Method for forming a staple
US20110087276A1 (en) 2009-10-09 2011-04-14 Ethicon Endo-Surgery, Inc. Method for forming a staple
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EP1374788A1 (fr) 2004-01-02
GB0214907D0 (en) 2002-08-07
GB2390024A (en) 2003-12-31
ATE527953T1 (de) 2011-10-15

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